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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 62-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
D52-9006948-8/2/3 15-Jan-2014 62BBY99 3006167812 Vinhtien Co., Ltd. Vietnam
 
241-8296612-7/2/1 09-Jan-2014 62CAR41 3009012685 Kumar Organic Products Limited, 100% Export Oriented Unit India
 
799-1831797-9/1/2 14-Jan-2014 62GCA48 3007517881 Macleods Pharmaeuticals Limited India
 
799-1904955-5/1/1 10-Jan-2014 62GCS20 3006767695 Apicore Pharmaceuticals PVT Ltd. India
 
946-0257710-1/1/1 08-Jan-2014 62GIY89 3002865753 Novartis Pharma Schweizerhalle Ag Switzerland
 
AMK-0014183-7/1/1 31-Jan-2014 62HAY99 3010078536 4e De Mexico Sa De Cv Mexico
 
AMK-0014192-8/1/1 31-Jan-2014 62HAY99 3010078536 4e De Mexico Sa De Cv Mexico
 
AMK-0014194-4/1/1 31-Jan-2014 62HAY99 3010078536 4e De Mexico Sa De Cv Mexico
 
AMK-0014193-6/1/1 31-Jan-2014 62HAY99 3010078536 4e De Mexico Sa De Cv Mexico
 
AMK-0014184-5/1/1 31-Jan-2014 62HAY99 3010078536 4e De Mexico Sa De Cv Mexico
 
799-1323730-5/1/1 16-Jan-2014 62IDS17 1000157701 Kyowa Hakko Kogyo Co Ltd Japan
 
M21-0749491-8/1/1 24-Jan-2014 62KAE08 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
799-1468133-7/1/2 03-Jan-2014 62LBO52 3001581899 Contract Pharmaceuticals Ltd. Canada
 
799-1468133-7/1/1 03-Jan-2014 62LBO52 3001581899 Contract Pharmaceuticals Ltd. Canada
 
UPS-6698951-1/4/1 03-Jan-2014 62MAY08 3007222546 FOSHAN AQUA GEL BIOTECH CO. LTD. China
 
UPS-6698534-5/16/1 03-Jan-2014 62MAY08 3009488145 Zhengjia Bangli Medical Products Co., Ltd. China
 
F23-9092932-1/1/1/D 13-Jan-2014 62MBC08 3004654833 Cadbury Nigeria Plc. Nigeria
 
AEK-1763301-3/1/3 16-Jan-2014 62OCA14 3010517661 Darin Bairuty Jordan
 
AEK-8303969-9/1/1 16-Jan-2014 62OCA14 3004101850 Pfizer Japan Inc. Japan
 
XXX-0203460-2/1/2 28-Jan-2014 62OCA14 3006127003 Caplin Point Laboratories India
 
UPS-3883585-8/2/2 31-Jan-2014 62OCA14 3002114834 Pfizer Propriety Limited Australia
 
UPS-3546903-2/1/1 09-Jan-2014 62OCY41 3010554588 Jaime Robles Chile
 
AEK-1763301-3/1/2 16-Jan-2014 62ODA18 3010517661 Darin Bairuty Jordan
 
799-2218775-6/1/1 17-Jan-2014 62QIR07 3003735909 Nantong Jinghua Pharmaceutical Co., Ltd. China
 
238-2001584-2/2/1 09-Jan-2014 62TIY04 3010175148 Advanced Accelerator Italy
 
D52-9006948-8/1/3 15-Jan-2014 62UBY99 3006167812 Vinhtien Co., Ltd. Vietnam
 
AEK-0817417-5/2/1 16-Jan-2014 62UCL99 3010489397 Valluvar Guruklum India
 
UPS-3314099-9/7/1 17-Jan-2014 62WBL17 3010506695 Rgm Pacific Australia
 
UPS-3314099-9/1/1 17-Jan-2014 62WBL17 3010506695 Rgm Pacific Australia
 
UPS-3314099-9/8/1 17-Jan-2014 62WBL17 3010506695 Rgm Pacific Australia
 
UPS-3314099-9/3/1 17-Jan-2014 62WBL17 3010506695 Rgm Pacific Australia
 
UPS-3314099-9/2/1 17-Jan-2014 62WBL17 3010506695 Rgm Pacific Australia
 
UPS-3314099-9/9/1 17-Jan-2014 62WBL17 3010506695 Rgm Pacific Australia
 
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